Projects

Consultancy and Legal Manufacturing Services

LEGAL MANUFACTURING

To date, Shin-Etsu silicone produces over 5,000 kinds of versatile silicone products. Decision has been taken by the management of the company to design and develop medical device and sell the device under own brand. The company had and established facility in Hungary which was focused on production of components for automotive and food segment.

Challenge

Because the company had no previous experience with medical device manufacturing and new upcoming regulations in the industry, the company decided to use silicone production expertise and build related infrastructure for production of Enteral feeding products in Hungary and use Sky Medical as the legal manufacturing partner.

Solution

Shin-Etsu engaged Sky Medical to plan and establish a medical device cleanroom production facility and infrastructure. Sky Medical was selected because of its ability to deliver a turnkey project - from planning to realization and validation of cleanroom and knowhow in establishing a Quality Management System (QMS) to MDR compliant technical file creation and management, assembly, packaging development and all related regulatory affairs concerning legal manufacturers.

Results

Production Facility: Planning, establishment and validation of a ISO 8 Clean room infrastructure for the production of medical products in Hungary.

CLEANROOM FACILITY ESTABLISHMENT

Challenge

Create a facility for the local, in-house production of sterile medical devices and products in Kazakhstan.

Solution

Engage Sky Medical in a turnkey project for the planning, realization, validation and the provision of consultant services for ongoing operation of the facility and establishment of a Quality Management System.

Results

ISO-certified facility and infrastructure.

Quality Management System for the production of sterile medical devices and products.

THERMOFORMING PACKAGING MACHINE

Sky Medical is investing in a new Multivac thermoforming packaging machine. The Multivac R145 enables high output and quick format change to be achieved, as well as making individual pack design possible.